Content Validity of the Premature Ejaculation Profile, Original and Per-Event Formats, in Men with Lifelong Premature Ejaculation.

Background: The Premature Ejaculation Profile (PEP) is a patient-reported outcome (PRO) measure that is widely used in clinical research in men with premature ejaculation (PE) but has not been fully validated for men meeting the current International Society for Sexual Medicine (ISSM) definition of lifelong PE. Aim: To explore the content validity of the PEP (original 1-month recall version and new event-driven version) in men meeting current definitions of lifelong PE and to understand the relevance of the concept of ejaculation control. Methods: In-depth individual interviews were conducted with 24 men in a stable heterosexual relationship, including 15 with lifelong PE, 4 with acquired PE (with intravaginal ejaculation latency time values confirmed during a 4-week period of no treatment), and 5 with no sexual dysfunction. Initial concept elicitation explored individual experiences of having PE (in those with PE), experiences of control, and impact on sexual life. This was followed by a cognitive debriefing of the PEP versions. Main Outcome Measure: Thematic analysis was used to identify key concepts of PE, understand the experience of control in men with and without PE, and confirm understanding and relevance of questions from original and event-driven versions of the PEP. Results: The interviews confirmed substantial negative consequences for men with lifelong PE. Men with and without PE could describe ejaculation control (or lack of it). The PEP was shown to cover the key concepts in PE, and the questions were easily understood in both the original or event-driven versions. The items were comprehensive, and the concept of ejaculation control was confirmed. A 1- or 2-category change in each item of the PEP was considered clinically meaningful. Clinical Implications: The PEP (original and per-event) has strong content validity for use in clinical research studies of men meeting the ISSM definition of lifelong PE. Strengths & Limitations: This study addressed gaps in previously published research on the development and validation of the PEP and also confirmed that a new event-driven version is also suitable for use in research. However, the study was limited mainly to men meeting a strict definition of lifelong PE; in addition, homosexual men and those not in stable long-term relationships were not studied. Conclusion: Both the original and per-event PEP versions were shown to have strong content validity and be acceptable for use in men with lifelong PE. Copyright (C) 2019, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.